ROi CPS LLC
66 recalls on record · Latest: Feb 12, 2025
FDA Devices Critical Feb 12, 2025
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
FDA Devices Moderate Sep 25, 2024
regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
FDA Devices Moderate Aug 28, 2024
Regard Kit containing the Microtek decanter
FDA Devices Critical Jan 24, 2024
regard Operative LAP, Item Number 800943001; surgical convenience kit
FDA Devices Critical Jan 10, 2024
Regard Dressing change kit, Item Number 800026006
FDA Devices Moderate Nov 22, 2023
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
FDA Devices Moderate Oct 11, 2023
GS0008 2Y - Burn Pack - STL, Item Number 880082025
FDA Devices Moderate May 3, 2023
Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
FDA Devices Moderate May 3, 2023
Sterile surgical convenience kit: regard Item Number: 800753005, GY00958E - WPH GYN Laparoscopy Pack.
FDA Devices Moderate May 3, 2023
Sterile surgical convenience kit: regard Item Number: 880393003, HT00997C - Cardiac Cath.
FDA Devices Moderate May 3, 2023
Sterile surgical convenience kits: 1. regard Item Number: 880353009, GS00797I - Laparotomy Pk; 2. regard Item Number: 880429002, GS01036B - Univ…
FDA Devices Moderate May 3, 2023
Sterile surgical convenience kits: 1. regard Item Number: 880473001, OR01105A - Total Shoulder/Hip; 2. regard Item Number: 880426004, OR01033D…
FDA Devices Moderate Nov 30, 2022
regard DAVINCI PACK, GS00137W, Item Number 880132023; gastric surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard BASIC NEURO, NU00259R, Item Number 800021018; neuro surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard RETINAL PACK, EY00935C, Item Number 800730003; EYE surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard NEURO PACK, NU00278L, Item Number 800040012; nuero surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard BASIC NEURO, NU00259S, Item Number 800021019; neuro surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard SPINE PACK, NU00260H, Item Number 800022008; ortho surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard HIP ARTHROSCOPY, OR01092B, Item Number 880462002; ortho surgery convenience kit
FDA Devices Moderate Nov 30, 2022
¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H, Item Number 830099008; cardiac surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard CERVICAL PACK, NU00303H, Item Number 800058008; neuro surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard SHOULDER PACK, GS00125V, Item Number 880120022; ortho surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard TOTAL HIP ARTHROPLASTY A&B, OR00032W, Item Number 880028023; ortho surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z, Item Number 880118026; ortho surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard MINOR NEURO, NU00140AD, Item Number 880135030; neuro surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard ACDF, NU00698H, Item Number 800246008; neuro surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard SHOULDER, GS00828G, Item Number 880367007; ortho surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard FOOT PACK, OR00123Y, Item Number 880118; orthopedic surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard SHOULDER ARTHROSCOPY, OR01103A, Item Number 880471001; ortho surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard SPINE, OR01100A, Item Number 880468001; ortho surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard LATERAL SHOULDER, OR01044C, Item Number 880435003; ortho surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard TOTAL JOINT, OR00446F, Item Number 880291; orthopedic surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard HAND PACK, OR00594K, Item Number 800243011; ortho surgery convenience kit
FDA Devices Moderate Nov 30, 2022
¿regard SHOULDER ARTHROSCOPY, OR00049Q, Item Number 880044017; ortho surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard CATARACT, EY00450K, Item Number 880295011; eye surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard CATARACT, EY00450L, Item Number 880295012; eye surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard ACDF, NU00698I, Item Number 800246009; neuro surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard MINOR DAVINCI PACK, GS00349M, Item Number 880251013; general surgery convenience kit
FDA Devices Moderate Nov 30, 2022
regard VITRECTOMY PK, EY00938C, Item Number 800733003; EYE surgery convenience kit
FDA Devices Moderate Jul 27, 2022
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
FDA Devices Moderate Jul 6, 2022
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
FDA Devices Moderate Jun 15, 2022
Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
FDA Devices Moderate May 4, 2022
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother;…
FDA Devices Moderate May 4, 2022
Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.
FDA Devices Low Apr 6, 2022
Regard Custom Procedure Kits containing BD Luer Lok Access Devices
FDA Devices Moderate Mar 9, 2022
Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile
FDA Devices Moderate Jan 19, 2022
Regard, T AND A - Rogers, sterilized convenience kits
FDA Devices Moderate Nov 24, 2021
REGARD Vitrectomy Tray
FDA Devices Moderate Nov 24, 2021